(29 days)
Not Found
No
The device description and intended use clearly describe a mechanical implant for spinal fixation, with no mention of software, algorithms, or any technology related to AI/ML.
Yes
The device is intended for temporary stabilization and aid in the development of a solid fusion in various conditions affecting the cervical spine, which are therapeutic goals.
No
The device description clearly states its purpose is for "anterior interbody screw fixation of the cervical spine" and for "temporary stabilization of the anterior spine during development of a solid fusion." This indicates a therapeutic and structural support function, not a diagnostic one.
No
The device description explicitly states that the system consists of multiple sized plates and screws fabricated from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a Cervical Plate system, which is a surgical implant used to stabilize the cervical spine. It is a physical device implanted into the body.
- Intended Use: The intended use clearly states it's for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during development of a solid fusion." This is a surgical procedure, not an in vitro test.
The device is a surgical implant used for structural support and stabilization within the body, not for analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:
- · degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- · pseudoarthrosis, and
- · failed previous fusion.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The Cervical Plate system consists of multiple sized plates and screws. All components are fabricated from anodized titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the cervical spine.
The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests: Testing was performed according to ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
SEP 2 4 2004
Cervical Plate 510(k) Summary August 24, 2004
Submitter Scient'x Batiment Calypso Parc Ariane 3 78284 Guyancourt FRANCE Contact person J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Trade Name Cervical Plate Common name Anterior cervical plate Classification name Class II per 21 CFR section 888.3060 Product Code KWQ Equivalent Device Scient'x Anterior Cervical Plate (K013439).
Device Description
The Cervical Plate system consists of multiple sized plates and screws. All components are fabricated from anodized titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. Fixation is provided by inserting screws through holes in the plate into the vertebral bodies of the cervical spine.
The screws utilized in the Cervical Plate are of the self tapping cortical type and are available in 04.0mm and a variety of lengths.
Intended Use
The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:
- · degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · s pondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · s pinal stenosis.
- · d eformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- · p seudoarthrosis, and
- · failed previous fusion.
However, this device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine
Summary of Technological Characteristics Compared to Predicate Device
The Cervical Plate is similar in indications, material, design, geometry, screw locking mechanism, length, strength, and screw diameter, length and thread form.
Summary Nonclinical Tests
Testing was performed according to ASTM F1717.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the shape of the bird's head, body, and tail.
Public Health Service
SEP 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scient'x C/o Mr. J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K042317
Trade/Device Name: Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2004 Received: August 26, 2004
Dear Mr. Webb:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roved above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surver in the encreases 976, the enactment date of the Medical Device Amendments, or to conniner of the ria) 2011-12-11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aroney manager of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reaso or as made a determination that your device complies with other requirements of the Act than - Drideral statutes and regulations administered by other Federal agencies. You must or any i vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo reter will and wy of substantial equivalence of your device of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Macer Eccurers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Millman
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _长۵५2 317
Device Name: Cervical Plate
Indications for Use:
The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with the following conditions:
- · degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- · pseudoarthrosis, and
- · failed previous fusion.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mulh A. M. M
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K042317